Page 3773 - Week 12 - Tuesday, 18 October 2005
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the smoking of cannabis and reliance on the illicit drug trade and could leave the government open to legal challenge in the future.
Another option available to the ACT is to establish a medicinal cannabis program in the ACT with cultivation and/or supply of cannabis. If a medicinal cannabis program was established in the ACT and cannabis cultivation was undertaken, there would be a requirement under international treaty arrangements for a government agency to designate the area under cultivation, license cultivators and purchase and take possession of the crop.
For a small jurisdiction such as the ACT, the resource and policing costs of this approach would be substantial. For cannabis to be supplied in the ACT, application would need to be made to the Therapeutic Goods Administration to exempt the importation of supply from restriction. Approval would be unlikely in the absence of a standardised medicinal product for use in a medical or scientific trial.
The last option open to the territory is for the ACT to seek to obtain Sativex for use in a select patient group after further testing overseas. Sativex is the safest and best option for providing a therapeutic cannabis product for the following reasons. It is standardised and pure, and safety and efficacy data are available. At present, there is only limited evidence of the safety and effectiveness of Sativex in a variety of neurological conditions. Sativex has been administered to small numbers, approximately 424 people, during clinical trials, with 110 people receiving Sativex for more than a year.
Three recent phase three trials have shown only minor benefits in pain control and relief of muscle spasm in multiple sclerosis and pain due to nerve damage, that is, neuropathic pain. A study in the UK involving 48 patients with pain due to nerve damage showed only a very small difference in pain levels in those using Sativex compared with a placebo. Sativex is not recommended for men intending to start a family or women of child-bearing potential unless they are on a reliable contraception or, indeed, those driving a motor vehicle or engaging in activities requiring unimpaired judgement and coordination.
In addition, over 70 per cent of users in the studies experienced an adverse event classified as an intoxication-type reaction. Symptoms most commonly reported were feeling drunk, sleepiness, disorientation and disturbance in attention. In long-term studies of Sativex, depression has been reported. A further study of the use of Sativex in 280 patients with multiple sclerosis is under way in the UK and results are expected in the northern spring of 2006.
Given all these options and the issues outlined in the report, which I am pleased to provide to members today, it is the government’s view that the ACT should await the results of the further studies into Sativex and reassess the safety and effectiveness of the product based on those results. For these reasons, the government has decided to await confirmation of the effectiveness and safety of Sativex from trials under way overseas. If Sativex is found to be safe and effective, the ACT could then seek to import it for use in a select patient group. As noted, this would require the cooperation of the commonwealth government and I would approach the federal health minister for approval in those circumstances.
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